Alcon Acrysof IQ IOL Recall: Incorrect Diopter Risk
Alcon recalls Acrysof IQ IOLs with incorrect diopter settings that may cause vision issues. Affected models include 20.5 D SP ACRYLIC FOLDABLE LENS with UltraSert delivery system. Contact Alcon for details.
Lower-risk recall
Incorrect IOL diopter
Contact the company
What happened, in plain English
Alcon is recalling certain Acryso: IQ IOL lenses due to an incorrect diopter setting. This could lead to vision problems if the lens is implanted. Affected products have specific model numbers and lot codes. Read more at govinfonow.com/recall/65363-alcon-acrysof-iq-iol-recall-incorrect-diopter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/65363-alcon-acrysof-iq-iol-recall-incorrect-diopter-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2287-2020
Cite this page
“Alcon Acrysof IQ IOL Recall: Incorrect Diopter Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65363-alcon-acrysof-iq-iol-recall-incorrect-diopter-risk. Based on FDA recall #Z-2287-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2287-2020%22&limit=1).
Why it’s dangerous
The IOL (intraocular lens) has an incorrect diopter setting, which means it may not focus light properly on the retina. This could cause vision problems but does not pose a direct risk of injury.
Who’s affected
People who have received the Acrysof IQ IOL with the incorrect diopter setting, particularly those who have had the lens implanted. The risk is low as the issue is related to the lens design rather than a safety hazard.
How to tell if you have this one
Check for model number AU00T0V205, lot number 12726594, or UDI # 038065GMN000065H7 on the product packaging. The product was sold with the UltraSert delivery system.
- Brand
Alcon- Category
Medical device
What to do — step by step
Check Product Details
Look for model number AU00T0V205, lot number 12726594, or UDI # 038065GMN000065H7 on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Iowa, Michigan, Nebraska, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Alcon recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2287-2020 (April 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2287-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.